Position: GMP Quality Assurance Consultant Cell & Gene Therapy Location: Boston, MA Duration: Long Term
Job Overview
We are seeking an experienced GMP Quality Assurance Consultant to provide quality oversight and compliance support for Cell & Gene Therapy manufacturing operations, validation, laboratory, engineering, and capital projects in a GMP-regulated environment.
Key Responsibilities
Provide GMP QA oversight for manufacturing operations, validation, analytical laboratories, and engineering activities.
Review and support Change Controls, Validation Protocols, Risk Assessments, GMP Investigations, and CAPA.
Support equipment qualification, calibration, preventive maintenance, and laboratory operations.
Review equipment, facility, and utility trending programs.
Support environmental monitoring (EM), routine testing, and facility control systems.
Collaborate with cross-functional teams to ensure GMP compliance and timely issue resolution.
Required Qualifications
5 8+ years of GMP Quality Assurance experience in pharmaceutical, biotechnology, or Cell & Gene Therapy environments.
Experience supporting GMP manufacturing operations, validation, and capital projects.
Strong knowledge of GMP, QA, CAPA, Root Cause Analysis, Change Control, Risk Assessments, and aseptic processing.
Experience with Veeva, Nuvolo, ViewLinc, or similar quality management systems.
Bachelor's degree in Engineering, Life Sciences, or a related field (Master's preferred).
Excellent communication, analytical, and problem-solving skills.